BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 17167962 · Received June 20, 2023

    Report

    Report Number
    3004753838-2023-123179
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 24, 2023
    Report Date
    June 20, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000866
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6 CODES: HEALTH EFFECT - CLINICAL CODE - DECREASED LEVEL OF CONSCIOUSNESS ¿ 4591¿ E014302.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2023. THE PATIENT REPORTED INACCURATE CGM VALUES. ON WEDNESDAY (B)(6), THE PATIENT EXPERIENCED A SYMPTOMATIC HYPOGLYCEMIC EVENT AS SHE ALLEGED HER CGM VALUES WERE HIGHER THAN HER BG. WHILE SHE WAS DRIVING TO PICK UP HER GRANDDAUGHTER, HER GLUCOSE DROPPED, SHE BECAME DIZZY, CONFUSED, ¿BLANKED OUT¿ AND ¿ENDED UP ON THE OTHER SIDE OF TOWN¿ IN AN UNFAMILIAR AREA. EMERGENCY MEDICAL SERVICES ENCOUNTERED THE PATIENT ON THE SIDE OF THE ROAD AND TREATED THE PATIENT WITH GLUCOSE GEL (CGM AND BG VALUES WERE NOT PROVIDED). POST-EVENT, THE PATIENT RETURNED HOME BUT COULD NOT RECALL HOW SHE GOT THERE. SHE EXPERIENCED BODY ACHES, LEG PAIN, BACK PAIN, AND DIFFICULTY COMPREHENDING POST EVENT. THE SENSOR HAD BEEN INSERTED INTO THE ABDOMEN AT THE TIME OF THE EVENT. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE BY DEXCOM TECHNICAL SUPPORT AND MEDICAL SAFETY TO SPEAK WITH THE REPORTER; NO OTHER DETAILS WERE OBTAINED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692392 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI 00386270000866

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other